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Monday, 6 May 2013

Soligenix expands product pipeline with new biodefense collaboration for melioidosis

Soligenix (OTCQB:SNGX), a biopharmaceutical company focused on developing products for inflammatory diseases as well as biodefense countermeasures, has seen its share price more than double since the start of the year, and it's easy to see why. A recent surge in progress and expansion in its pipeline of drugs have been underway at the company, which just recently penned a deal to develop a treatment for melioidosis, an often lethal disease, through a worldwide exclusive collaboration with Intrexon.

Intrexon, a synthetic biology company, uses its proprietary technologies to provide control over cellular function. Under the agreement between the two parties, Soligenix says it plans to develop and commercialize human monoclonal antibody therapies for new biodefense and infectious disease applications for melioidosis, using Intrexon's isolation and production technologies.

Melioidosis, which has the potential for widespread dissemination, is endemic in Southeast Asia and Northern Australia, and is considered a high-priority biodefense threat as defined in last year's Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy, established by the U.S. Department of Health and Human Services.

The disease, for which there is no preventative vaccine or effective immunotherapy, is caused by Burkholderia pseudomallei, a Gram-negative bacteria that is highly resistant to antibiotic treatment, with mortality rates as high as 40 percent in many parts of Southeast Asia, according to recent stats - making melioidosis the third most common cause of death from infectious disease in that region after HIV/AIDS and tuberculosis.

With the collaboration, Intrexon will develop therapeutic antibody candidates targeting the disease, while Soligenix will undertake preclinical and clinical development, as well as regulatory and government interactions, and commercialization.

The companies termed the agreement as "unique" because of their goal to develop a therapy that will treat both a deadly disease, as well as fight a potential "biological weapon".

"Our collaboration with Intrexon is consistent with our corporate strategy of building shareholder value through continuous evaluation of new product opportunities and acting upon those that meet Soligenix's mission of delivering disease-modifying therapies in areas of high unmet medical need," president and CEO of Soligenix, Dr. Christopher J. Schaber said in a statement.

"By working with Intrexon we hope to make a potentially life-saving therapy available to patients in endemic regions and include the therapy in the national stockpiling program in case of a biowarfare event."

Other terms of this deal include Soligenix issuing Intrexon 1.034 million shares of its common stock, representing 8.5 per cent of the company's issued and outstanding shares, with Intrexon given the right to participate in future share offerings by Soligenix.

Soligenix will also pay development milestones and royalties on net sales derived from the products developed from the collaboration.

"Soligenix has the expertise and highly focused mission we look for in all our collaborations," said Randal J. Kirk, founder, chairman and CEO of Intrexon, which just completed a fresh $150 million financing for a whole new slate of collaborations in synthetic biology, with significant contributions from the billionaire founder and his venture fund, Third Security. "Although we are engaging with increasingly larger enterprises in Health, Food, Energy and Environment, we shall continue to explore powerful combinations with smaller, specialized companies that have great teams, grand vision and deep expertise."

Indeed, New Jersey-based Soligenix last week announced its first quarter results, saying revenues for the three months to March 31 were $0.9 million, up from $0.6 million in the year-ago period, while also listing off its accomplishments in the latest period.

Revenues increased in the quarter due to reimbursable costs from the company's four active government-funded programs - most notably its ThermoVax thermostability technology grant focused on a new method of rendering "aluminum salt adjuvanted vaccines" stable at elevated temperatures.

For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, Soligenix has said that the use of ThermoVax, which has been tested in combination with the company's RiVax vaccine, can lead to easier storage and the distribution of strategic national stockpile vaccines in emergency situations.

The company also highlighted the submission of a contract proposal to the Biomedical Advanced Research and Development Authority (BARDA) in the quarter, to support the development of OrbeShield. The award has the potential to be a multi-million dollar contract.

OrbeShield, also a part of Soligenix's biodefense platform, is being developed by the company to treat gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.

In addition, in its biotherapeutics segment, the company recently received FDA clearance of its investigational new drug application for SGX942, its lead compound, which is projected to enter phase 2 trials for oral mucositis in head and neck cancer in the second half of this year, with results anticipated in the second half of 2014.

In light of the recent progress, shares of Soligenix are currently trading at $1.40 - up 133 per cent since January 2, giving the company a market capitalization of almost $16 million, with 11.2 million shares outstanding.